PALO ALTO, Calif. - BridgeBio Pharma Inc . (NASDAQ:BBIO) announced positive results from its Phase 3 ATTRibute-CM study of acoramidis, which is under investigation for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), a progressive and fatal heart disease. The study findings were presented at the European Society of Cardiology (ESC) Heart Failure Congress 2024.
The ATTRibute-CM study, which included 632 participants, found that acoramidis significantly reduced all-cause mortality in the intention-to-treat population, with a p-value of 0.04, indicating a statistically significant outcome. Additionally, among the 21 participants with Stage 4 chronic kidney disease (CKD), treatment with acoramidis resulted in a 25% relative risk reduction in deaths at Month 30 compared to placebo.
The study also reported that acoramidis treatment led to a statistically significant and clinically important reduction in the progressive decline in health-related quality of life, as assessed by the EuroQoL Health Outcomes Assessment tool, EQ-5D-5L.
Furthermore, the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score indicated that acoramidis treatment reduced the decline in health status and quality of life, with consistent benefits observed in individual KCCQ domains.
According to Dr. Steen Hvitfeldt Poulsen, the study breaks new ground by including patients with eGFR less than 25 mL/min/1.73m2, a measure of kidney function, and demonstrates acoramidis's safety profile in this high-risk population.
BridgeBio has submitted a New Drug Application for acoramidis to the U.S. Food and Drug Administration with a Prescription Drug User Fee Act (PDUFA) action date of November 29, 2024. A Marketing Authorization Application has also been submitted to the European Medicines Agency, with a decision expected in 2025.
BridgeBio has granted Bayer (OTC:BAYRY) exclusive rights to commercialize acoramidis for ATTR-CM in Europe, leveraging Bayer's expertise in cardiovascular disease and BridgeBio's focus on genetic diseases and cancers.
This report is based on a press release statement from BridgeBio Pharma, Inc.
InvestingPro Insights
Following the announcement of positive results from the Phase 3 ATTRibute-CM study by BridgeBio Pharma Inc. (NASDAQ:BBIO), the company's financial metrics and analyst outlooks provide additional context for investors. According to InvestingPro data, BridgeBio Pharma's market capitalization stands at approximately $5.45 billion, reflecting the market's valuation of the company post-study results. Despite the lack of profitability in the last twelve months, analysts are optimistic about the company's sales growth, with a notable revenue growth of 181.05% in the last twelve months as of Q1 2024. This optimism is further bolstered by two analysts revising their earnings upwards for the upcoming period.
The InvestingPro Tips highlight that while analysts do not anticipate BridgeBio Pharma will be profitable this year, the company has shown a high return over the last year, with a 1 Year Price Total Return of 114.84%. Additionally, the company's liquid assets exceed its short-term obligations, indicating a solid liquidity position. However, it is important to note that BridgeBio is trading at a high revenue valuation multiple and does not pay a dividend to shareholders, which may be relevant considerations for potential investors.
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